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Hamburg Shifts Boxes at FDA

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Typical of new administrations, FDA commissioner Margaret Hamburg is moving around some staff functions and bringing in new faces, but holding off on major reorganizational changes at the agency. There will be a new “food czar”—a deputy commissioner of food—but not a comparable official in charge of drugs, biologics and medical devices. Hamburg also is looking for a politically savvy health expert to head up a new Center for Tobacco Products, plus other newcomers to direct revised operations for managing policy, budget, science and communications functions in the FDA commissioner’s office.

The departure of the remaining top staffers under the previous administration—chief of staff Susan Winckler, policy chief Randall Lutter and chief of operations John Dyer—facilitates these changes. Budget development will shift to the policy office to better meet demands from Congress for more detailed information on how FDA will spend all the added money it’s seeking. An office of external affairs will handle FDA’s relations with the media, health professionals and interest groups, and a new Office of Special Medical Programs is slated to absorb a number of cross-cutting programs—bioresearch monitoring, combination products, orphan drugs and pediatrics.

That will leave chief scientist Jesse Goodman to focus on innovation and counter-terrorism, in charge of FDA’s Critical Path Initiative and pandemic response. Goodman also will head up a new office of scientific integrity that will resolve scientific disputes within the agency, and share oversight of the Center for Toxicological Research in Arkansas.

But Hamburg’s main focus clearly is on improving food safety and oversight. The commissioner proposed these changes to the secretary of Health and Human Services (HHS) in June, just as the Obama administration rolled out new proposals from its food safety working group to better control food-borne illness. As part of the initiative, FDA issued a long-awaited final rule for reducing salmonella contamination in eggs and promised new guidance on ways to prevent E.coli contamination of tomatoes, melons and leafy greens.

At the same time, Hamburg announced the return of former FDA official and food regulatory expert, Michael Taylor, as a special advisor on foods. The expectation is that Taylor will be new food czar, overseeing the Center for Food Safety and Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM), along with extensive food-related oversight provided by FDA’s field force. Taylor comes to FDA with the benefit of experience as administrator of the Department of Agriculture’s Food Safety and Inspection Services (FSIS) as well as FDA deputy commissioner for policy in the early 1990s. As an academic for the last 10 years, Taylor has been involved in food safety research and policy. He has backed proposals to create a single federal agency governing food safety, but says that’s off the table for now.

Bigger Budget

Hamburg will have support for reorganization and expansion in the form of a $3 billion budget for the coming year. House and Senate spending bills provide FDA with $2.3 billion in appropriated funds plus some $600 million in user fees. The legislators specify increases in funds for generic drug approvals and instruct FDA to use much of the added money to increase inspections of food and drug operators, examine more imports, upgrade lab equipment and improve information technology.

There are special earmarks for research on food-borne contaminants, neuroblastoma, dietary guidelines and the impact of Risk Evaluation and Mitigation Strategies for drugs. The Senate bill earmarks $18 million for the Critical Path Initiative, along with research on tropical diseases, tuberculosis treatment, antibiotics and the bioequivalence of anti-epileptic drugs.

Differences in the specifics will be ironed out this fall, with an eye to approving final agency funding before the new fiscal year begins Oct. 1 – a major accomplishment after years of missed funding deadlines.

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